BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2041284 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02405
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 5, 2008
    Report Date
    March 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. REPORTEDLY, NO PRE-DILATATION WAS PERFORMED PRIOR TO PLACING THE XIENCE V STENT INSIDE A RESTENOSED STENT. THE IFU STATES THAT THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS. ADDITIONALLY, THE IFU STATES THAT THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IT IS UNKNOWN HOW, IF AT ALL, THIS MAY HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST DIRECT STENTING PROCEDURE IN A 100% RESTENOSED, NON-ABBOTT STENTED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY WITH ONE 3.5 X 18 XIENCE V STENT, THE PATIENT EXPERIENCED CHEST PAIN WITH ELEVATED CARDIAC ENZYMES WHICH WAS DIAGNOSED AS A NON-ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS PLACED ON A NITROGLYCERIN INFUSION AND THE PATIENT'S ACE INHIBITORS AND BETABLOCKERS WERE INCREASED. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2008 AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8073062

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R| S